Clene Reports First Quarter 2024 Financial Results and Recent Operating Highlights By Investing.com

• Data from long-term extension of Phase 2 VISIONARY-MS clinical trial of CNM-Au8 ® demonstrated significant evidence of repair and remyelination across multiple paraclinical endpoints (change from original baseline, p<0.05)
• Peer-reviewed publication characterized the protein corona of CNM-Au8
• Company received sub-award of $7.3 million from NIH grant for ALS Expanded Access Program
• Cash, cash equivalents and marketable securities of $27.9 million as of March 31, 2024

SALT LAKE CITY, May 08, 2024 (GLOBE NEWSWIRE) — Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, Clene) and its wholly owned subsidiary Clene Nanomedicine, Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced its first quarter 2024 financial results and provided recent operating highlights for the CNM-Au8 clinical program for MS.

In the first quarter our team worked diligently to advance our FDA discussions in ALS while continuing to generate more data supporting the neurological benefits and mechanism of action of CNM-Au8, said Rob Etherington, President and CEO of Clene. We look forward to a productive and collaborative FDA meeting by mid-2024 and laying the groundwork towards filing of a New Drug Application in the second half of the year. Additionally, we are very pleased to see the recent data from our long-term extension of the VISIONARY-MS study. These data represent significant evidence of repair and remyelination across multiple paraclinical endpoints and provide us with greater support for the continued clinical evaluation of CNM-Au8 for this important indication.

First Quarter 2024 and Recent Operating Highlights

CNM-Au8  for the treatment of MS

• In April, the Company announced at the 2024 American Academy of Neurology (AAN) Annual Meeting clinical data demonstrating that long-term CNM-Au8 treatment produced significant evidence of repair and remyelination across multiple paraclinical endpoints. Participants originally randomized to CNM-Au8 treatment experienced continued significant improvement in vision as measured by low contrast letter acuity. More than half of participants improved by 10 or more letters on a low-contrast Sloan eye chart, with increases of up to 38 letters (mixed model repeat measures, or MMRM vs….